Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis (CY25)

National Research Center for Hematology, Russia

Status and phase: Not yet enrolling; Phase 3

Conditions: Hematologic Malignancy; Graft Versus Host Disease; Cyclophosphamide Adverse Reaction

Treatments: Drug: Post-transplantation Cyclophosphamide at dose 50 mg/kg/day; Drug: Post-transplantation Cyclophosphamide at dose 25 mg/kg/day

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05158608

CY25

Details and patient eligibility

About

This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have an indication for allogeneic hematopoietic stem cell transplantation

Exclusion criteria

• Uncontrolled bacterial or fungal infection at the time of enrollment
• Requirement for vasopressor support at the time of enrollment
• Karnofsky index <30%
• Pregnancy
• Somatic or psychiatric disorder making the patient unable to sign informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day

Active Comparator group

Description:

Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.

Treatment:

Drug: Post-transplantation Cyclophosphamide at dose 50 mg/kg/day

Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day

Experimental group

Description:

Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.

Treatment:

Drug: Post-transplantation Cyclophosphamide at dose 25 mg/kg/day